New FDA Commissioner Nominee Recognises Medical Value Of Marijuana
A new commissioner for the FDA will be nominated by U.S. President Joe Biden. This new Food and Drug Administration commissioner has already acknowledged the potential medical benefits of marijuana. In fact, a doctor has prescribed him medicine that derives from cannabis. Once serving a short stay at the FDA head Robert Califf has not spoken on concerns with cannabis. Yet back in 2016 at a research summit about marijuana, he recognized the healing power of the plant. To which Mr. Califf strongly suggested the FDA is ready to push for cannabis research and development.
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“We understand that people have identified a number of possible uses of marijuana and marijuana-derived products. For example, AIDS wasting, epilepsy, neuropathic pain, treatment of spasticity associated with multiple sclerosis, cancer and chemotherapy-induced nausea,” Califf said. “And I had the chance to prescribe some of this in my cardiology practice in people with extreme heart failure who get a wasting cachectic syndrome.”
Notably, he also said that while FDA had yet to find that botanical marijuana is “safe and effective for any indication,” that’s not to say there aren’t any good uses for it, and additional studies could shed light on the situation.
FDA’s position on cannabis is “not because we’ve had a ton of applications to look at,” he pointed out. “It’s because we haven’t gotten them into the pathway,” Califf said. “What this means is that no one has demonstrated to FDA that any such product is safe or effective for the treatment of any disease or condition. To change that we need studies conducted using marijuana to rigorously assess the safety and effectiveness of marijuana for medical use.”
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“Then we need to get those studies submitted to FDA and a marketing application for review under the legal standard set out in the federal Drug and Cosmetic Act,” he said. “This assures that the drug product meets the statutory standards for approval.”
“This is what we really want and we actively encourage it and want to work with people to make this happen,” he added. “To do this, we know we need to facilitate the work of companies interested in appropriately bringing safe, effective and quality products to market, including scientifically based research concerning these medicinal uses.”
“We believe this process, which includes collaboration with other federal and state agencies, researchers and manufacturers working on issues related to the use of cannabidiol and other constituents of marijuana in the U.S. remains the best way to identify new treatments that are safe and effective for patients and to protect patients from products that are not what they purport to be.”
At the summit, Califf also pointed out that FDA has approved synthetic cannabis products. For example products like Marinol which is used for a variety of health ailments.
The approval of these substances “supports the point I made earlier that our decisions on the approval of any medicine relies on the science to determine the safety and effectiveness of new medicines. And it’s also consistent with the approach we’ll continue to take going forward in this area,” he said.
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In its entirety, the comments imply that, if confirmed, Califf wouldn’t be opposed to examining the healing powers of cannabis. Although he does seem to defer to statutory processes within FDA. A particular process that sides with pharmaceutical approaches to these remedies. Yet this stance has so far retained marijuana in a small regulated drug classification.
In a separate case, some vaping stakeholders have raised concerns about the prospective nominee. This has led to a 2019 op-ed he created that advocated for a ban on flavored vape products. Mainly this was done as a way to mitigate the risks of the e-cigarette or vaping use-associated lung injury crisis.
“I believe that we should move to enact strict regulation to limit the harm done by vaping products, augmented by an aggressive public education program that is particularly aimed at vulnerable young people, but not excluding adults,” Califf wrote at the time.
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However, he acknowledged that an “outright prohibition of vaping products seems impracticable on several grounds,” adding that the “regime of legal prohibition also dissuades people from seeking help with addiction for fear of stigma that might negatively affect future employment and social mobility.”
If Califf does become commissioner, he’ll have a long road ahead dealing with cannabis. For instance, those invested in the industry are anxiously awaiting action by the FDA. If all goes well the FDA may allow CBD to be marketed as a food item or dietary supplement. The FDA has stated that on its journey with cannabis but bipartisan legislators have proposed legislation this session. Which has forced the FDA to make a change.
The FDA will play a significant role in any progress to reschedule cannabis. If a scheduling petition is accepted, the FDA has to assess the medical and public health connections. A process that would need to be done before submitting that examination to the Justice Department with its recommendations.